Sr. CSV/CQV Specialist

Merck & Co.; Raritan (NJ); On-site; USD 110,706 - 145,303; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) with company match

Paid parental leave

Paid time off

Job summary

Legend Biotech is seeking a Sr. CSV Specialist to join the Manufacturing & Supply team in Raritan, NJ. The role provides commissioning, qualification and validation support for computerized systems in CAR-T cell therapy manufacturing, ensuring data integrity and regulatory compliance.

You will own CSV/CQV protocols, manage complex projects, and collaborate with SAP, MES, and other systems, with emphasis on CQV and risk assessments. Strong GMP knowledge and team leadership are essential.

Qualifications

• Bachelor's Degree in Science, Engineering or equivalent.
• Minimum 2 years in 21 CFR 11, 58, 210, 211 and ICH guidelines with GMP data integrity.
• Aseptic manufacturing or cell therapy experience is preferred.

Responsibilities

• Serve as SME for 21 CFR Parts 210, 211, 11 and EU Annex 11.
• Execute commissioning, qualification, requalification, validation activities.
• Manage multiple CSV projects with CQV standards and cross-functional coordination.
• Support technical investigations, CAPAs and remediation activities.
• Author CSV/CQV protocols, summary reports and data for regulatory conformance.
• Create, revise and review change controls, SOPs and related docs.
• Prepare risk assessments, FMEAs, periodic qualifications, and master plans.
• Handle biological materials and hazardous chemicals safely as required.

Skills

CSV expertise

Regulatory knowledge

GMP compliance

Project management

Communication

Education

Bachelor's Degree in Science/Engineering

Tools

SAP

MES

Maximo

TrackWise

Job description

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.

Legend Biotech is seeking a Sr. CSV Specialist as part of the Manufacturing & Supply team based in Raritan, NJ.

Role Overview

This position will be responsible for providing Commissioning, Qualification and Validation support to all computerized systems in the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will be responsible in handling day-to-day activities inclusive of execution, protocol management, vendor management, issues, deviations, corrections and remediation efforts of computerized systems for facility, equipment, systems and processes in support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements. This role will require CSV and engineering experience, ownership and leadership, ability to work independently, drive effective communication, coordination and collaboration across relevant cross functional groups to establish a strong, compliant CSV program to enable robust production, testing and release of product to patients.

Key Responsibilities

• Acts as the subject matter expert (SME) for 21 CFR Parts 210, 211, 11, EU Annex 11 among others.
• Works with above plant center of excellence (COE) to successful implement and maintain tools, standards, policies and procedures in compliance.
• Executes the commissioning, qualification, requalification, validation and any associated activities within the plant of all computerized systems such as SAP, MES, manufacturing and laboratory equipment, BAS, EDS and other software and systems.
• Manages multiple and complex CSV projects in accordance with CQV, provides status reports and coordinates with other departments or outside contractors/vendors to complete tasks.
• Supports and/or owns technical and quality investigations, CAPAs and corrections.
• Develops and performs any required remediation efforts and associated CAPA plans.
• Authors, owns and executes master and completed CSV/CQV protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria, specifically data integrity.
• Executes, owns, assesses and participates in the creation, revision and review of change controls, SOPs, and other documentation.
• Participates in authoring Risk Assessments, FMEAs, Periodic Qualifications, Project Plans, Master Plans, and Annual Product Review.
• Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals.

Requirements

• A minimum of a Bachelor's Degree in Science, Engineering or equivalent technical discipline is required.
• A minimum of 2 years relevant work experience is required with expertise in 21 CFR Part 11, 58, 210 and 211, Eudralex regulations and ICH guidelines. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance, or manufacturing compliance
• Expertise in GMP compliance knowledge including knowledge of 21 CFR Part 11, EU Annex 11 among others
• Experience with ICH and/or 21 CFR parts 210, 211, 1271 is required and 600, 601, and 610 is preferred.
• Thorough knowledge and understanding of GMP data integrity standards
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices.
• Strong interpersonal and written/oral communication skills.
• Ability to quickly process complex information and often make critical decisions with limited information.
• Proficient in applying process excellence tools and methodologies.
• Ability to independently be responsible for a portfolio of ongoing projects.
• Ability to pay attention to details and follow the procedures.
• The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
• Good written and verbal communication skills are required.
• Ability to summarize and present results, and experience with team-based collaborations is a requirement.
• Ability to work with others in a team environment.
• Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP) related to CAR-T manufacturing or cell processing.
• Ability to identify/remediate gaps in processes or systems.
• Experience authoring and executing documentation including but not limited to: Batch Records, SOPs, Work Instructions, protocols.
• Experience with TrackWise, CMMS and Maximo.
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint).

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#Li-Onsite

The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws.

Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.

Benefits and Paid Time Off: Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

Pay Range (Base Pay):

$110,706—$145,303 USD

Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.

Work Authorization & Employment Eligibility

Applicants must be authorized to work in the United States. As part of our commitment to maintaining a lawful workforce and ensuring compliance with federal employment regulations, we participate in the E-Verify program. If you are selected for employment, you will be required to complete the Form I-9 process, and your employment eligibility will be verified through E-Verify in accordance with applicable federal law. We are committed to providing a fair, transparent, and welcoming hiring experience for all candidates.

EEO Statement

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.

For information related to our privacy notice, please review: Legend Biotech Privacy Notice.